Reference
Implant & Tissue Compliance Tracker glossary
Terms used in Implant & Tissue Compliance Tracker and its documentation.
Applies to Implant & Tissue Compliance Tracker as it works today. Moraph updates the platform continuously, and this page is reviewed when it changes.
Terms used in Implant & Tissue Compliance Tracker and its documentation.
| Term | Meaning |
|---|---|
| Device identifier (DI) | The part of a unique device identifier that names the device model and version. |
| Production identifier | The lot, serial, expiration or manufacture date part of a unique device identifier. |
| GUDID | The FDA's public Global Unique Device Identification Database of device identifiers and attributes. |
| ISBT 128 | A labeling standard used for tissue and other products of human origin. |
| Distinct identification code | The code a tissue supplier assigns so a graft can be traced to its donor. |
| Disposition | What finally happened to an item: implanted, wasted, returned or discarded. |
| Temperature excursion | A period when a storage unit was outside its acceptable range, requiring review of the items inside. |
| Quarantine | Holding an item out of use until someone decides to release, return or discard it. |
| Tracked device | A device that 21 CFR Part 821 requires to be traceable to the patient who received it. |
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